期刊
EUROPEAN NEUROLOGY
卷 62, 期 1, 页码 40-48出版社
KARGER
DOI: 10.1159/000216839
关键词
Parkinson's disease; Pardoprunox (SLV308); Partial dopamine agonist; Titration
资金
- Solvay Pharmaceuticals B.V., Weesp, The Netherlands
- Bayer Schering Pharma AG
- Bertek
- Boehringer Ingelheim
- Centopharm
- Eisai Ltd.
- Genzyme
- GlaxoSmithKline
- Impax
- Kyowa Pharmaceutical
- Merck KgaA
- Novartis
- Ortho McNeil
- Pfizer
- Prestwick
- Schwarz Pharma
- Schering
- Teva Neuroscience
- Valeant
- Vernalis
- Astellas
- Brane
- Fujisawa
- Gruenthal
- Kyowa
- Lundbeck
- Neurobiotech
- Newron
- Schering-Plough
- Serono
- Servier
- UCB
- Xytis
- Boehringer-Ingelheim
- Ceregene
- Medtronic
Aims: To investigate the safety and tolerability of pardoprunox (SLV308), a novel partial dopamine agonist, as an adjunct to levodopa in patients with advanced Parkinson's disease, using two titration schedules. Methods: Patients were randomized to pardoprunox (n = 51) or placebo (n = 11). Pardoprunox was titrated to the highest tolerated dose (range, 0.3-42 mg/day) over 7 weeks, using a gradual dose escalation without intermediate steps (group 1) or with intermediate steps (group 2). Results: The cumulative drop-out rate was greater in group 1 (without intermediate steps, 56.0%) than in group 2 (with intermediate steps, 34.6%), or with placebo (9.1%). In group 2, doses up to 18 mg/day were well tolerated with a cumulative drop-out rate of 7.7% (2/26) and a drop-out rate due to adverse events of 4.0% (1/26). The most common adverse events reported were nausea, vomiting, headache, and dizziness. There was a trend for reduced OFF time (p = 0.054) in the combined pardoprunox group compared to placebo. Conclusions: The pardoprunox safety and tolerability profile as an adjunct to levodopa was improved using a gradual titration schedule that included intermediate dose steps. Using this titration, doses up to 18 mg/day were well tolerated. Copyright (C) 2009 S. Karger AG, Basel
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据